The Combating Alzheimer's through Sleep and Exercise (CASE) study is an exploratory, hypothesis-generating trial designed to: (1) assess whether improvements in sleep are associated with improvements in cognitive performance and cardiovascular and metabolic health; (2) evaluate the effects of structured, moderate-level aerobic and anaerobic exercise on cognitive performance and cardiovascular and metabolic health; (3) examine the combined, potentially synergistic effects of both interventions on cognitive performance and cardiovascular and metabolic health; and (4) investigate the role of light exposure as a potential modulator of sleep parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The Elemind Neuromodulation headband is a wearable device that utilizes noninvasive, electroencephalography-based (EEG-based) technology to induce a sleep state more rapidly via personalized acoustic stimulation. Specifically, the headband uses a closed-loop system, meaning that the headband conveys stimulation based upon recorded neural activity in order to modulate real-time oscillating circuits at the macroscopic level. This device uses five dry, flexible EEG electrodes-including three recording electrodes that are positioned at the Fpz and Fp1/2 electrode sites in accordance with the 10-20 International System of electrode placement and two silicone rubber-based, linked reference electrodes located at the mastoids-to measure neural activity during sleep and provide an estimation of the phases of real-time neural oscillations. The headband generates a sound pulse by identifying alpha neural oscillations in real-time through endpoint-corrected Hilbert Transform algorithm.
Participants randomized to the exercise-only group will engage in an 8-week, home- and site-based exercise intervention designed for older adults across a range of cognitive and physical function levels. All site-based sessions will occur in-person at the study facility under supervision of trained staff. Each week, participants will attend two 60-minute structured exercise sessions, consisting of aerobic training and resistance training. On the remaining five days when subjects will not engage in structured exercise, subjects will be asked to engage in 30 minutes of moderate-intensity walking activities. In-lab exercise protocols will be fully standardized to ensure consistency of exercise dosage and fidelity across participants. The target exercise load will be 270 minutes of moderate-intensity exercise weekly for 8 weeks.
University of Miami Hospitals
Miami, Florida, United States
RECRUITINGGlycated Hemoglobin (HbA1c) Levels
Measured from blood sample
Time frame: Up to Week 8
Total Cholesterol Levels
Measured from blood sample
Time frame: Up to Week 8
Triglycerides Levels
Measured from blood sample
Time frame: Up to Week 8
High-sensitivity C-reactive protein (hs-CRP) Levels
Measured from blood sample
Time frame: Up to Week 8
Low-Density Lipoprotein (LDL) Levels
Measured from blood sample
Time frame: Up to Week 8
C-Peptides
Measured from blood sample
Time frame: Up to Week 8
High-Density Lipoprotein (HDL) Levels
Measured from blood sample
Time frame: Up to Week 8
Cognitive Function
Cognitive function gauged from Altoida's Digital Neuro-Signatures
Time frame: Up to 8 weeks
Insulin Levels
Measured from blood sample
Time frame: Up to 8 weeks
Neurofilament light chain
Measured from blood sample
Time frame: Up to Week 8
Total Sleep Duration
Measured from Elemind
Time frame: Up to Week 8
Slow Wave Sleep Duration
Measured from Elemind
Time frame: Up to Week 8
%Slow-wave Sleep
Measured by Elemind headband
Time frame: Up to Week 8
Rapid Eye Movement Duration
Measured by Elemind headband
Time frame: Up to Week 8
%REM
Measured by Elemind headband
Time frame: Up to Week 8
Light Non-Rapid Eye Movement Duration
Measured by Elemind headband
Time frame: Up to Week 8
%Light Non-Rapid Eye Movement Sleep
Measured by Elemind headband
Time frame: Up to Week 8
Sleep Efficiency
Measured by Elemind headband
Time frame: Up to Week 8
Sleep Onset Latency
Measured by Elemind headband
Time frame: Up to Week 8
Restlessness (Restless Bouts/Hour during Sleep)
Measured by Elemind headband
Time frame: Up to Week 8
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